Respiratory Depression During an Analgosedation Combining Remifentanil and Ketamine in TCI for Oocyte Retrieval

March 9, 2018 updated by: Luc Barvais, Erasme University Hospital

Study of Respiratory Depression During Analgosedation Technique Combining Remifentanyl and Ketamine in TCI for Oocyte Retrieval

This study evaluates the effect of the addition of ketamine to a conscious sedation protocol including remifentanil during oocyte retrieval. The investigators will have 2 groups with different target effect site concentrations, namely 150 ng/ml and 200 ng/ml.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The actual protocol for conscious sedation during oocyte retrieval in at the Erasmus hospital (Brussels) consists of Remifentanil in TCI-mode, with premedication by Midazolam. However, episodes of bradypnaea with or without desaturation are still common.

The primary objective is to observe if with the addition of ketamine, it is possible to significantly reduce the dose of Remifentanil, in order to avoid episodes of respiratory depression caused by the opioid.

The secondary outcomes measured, will be the pain levels experienced by the patient, the sedation level, and the satisfaction of the patients after the procedure.

Study Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Female patients in good health, with informed consent, undergoing oocyte retrieval at the Erasmus Hospital.

Description

Inclusion Criteria:

  • patients having an oocyte retrieval

Exclusion Criteria:

  • BMI > 30
  • endometriosis
  • contraindications to ketamine

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ketamine 150 ng/ml
The first group will receive the classical premedication with 2 mg of Midazolam. A bolus dose of Ketamine will be given, then to be titrated in TCI mode with a target concentration of 150 ng/ml. Right after, the Remifentanil TCI will be started at a concentration of 1 ng/ml and the procedure can begin.
Drug: Ketamine 150 ng/ml
conscious sedation in TCI-mode
Other Names:
  • conscious sedation
Drug: Remifentanil
conscious sedation in TCI-mode
Other Names:
  • conscious sedation
Procedure: Oocyte retrieval
Oocyte retrieval for In Vitro Fertilization
ketamine 200 ng/ml
The second group will be treated in the exact way as the first, with the exception that the target effect site concentration is aimed at 200 ng/ml.
Drug: Remifentanil
conscious sedation in TCI-mode
Other Names:
  • conscious sedation
Procedure: Oocyte retrieval
Oocyte retrieval for In Vitro Fertilization
Drug: Ketamine 200 ng/ml
conscious sedation in TCI-mode
Other Names:
  • conscious sedation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
respiratory depression
Time Frame: through study completion, an average of 2 months
respiratory rate (number of inspiration per minute)
through study completion, an average of 2 months
Respiratory depression
Time Frame: through study completion, an average of 2 months
SpO2 (%)
through study completion, an average of 2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain
Time Frame: through study completion, an average of 2 months
EVA
through study completion, an average of 2 months
patient satisfaction
Time Frame: through study completion, an average of 2 months
satisfaction scale: 1=unsatisfied. 2=average satisfaction 3=Satisfied 4=very satisfied. The higher the value, the better. Additionally, we ask the patients if they would choose the same anesthetic method, should it be necessary to repeat the procedure. If yes, it is considered a better outcome.
through study completion, an average of 2 months
pregnancy rate
Time Frame: 15 days after the oocyte retrieval
HCG in the blood
15 days after the oocyte retrieval
ketamine dosage
Time Frame: through study completion, an average of 2 months
blood sample (serum)
through study completion, an average of 2 months
sedation level
Time Frame: through study completion, an average of 2 months
OAAS: Observer's Assessment Of Alertness/Sedation Scale. 5=Responds readily to name spoken in normal tone. 4=Lethargic response to name spoken in normal tone. 3=Response only after name is called loudly and/or repeatedly. 2=Response only after mild prodding or shaking. 1=Response only after paintful trapezius squeeze. 0=No response after paintful trapezius squeeze. Values higher than 3 represents a better outcome.
through study completion, an average of 2 months
Arterial pressure
Time Frame: through study completion, an average of 2 months
mmHg
through study completion, an average of 2 months
Heart rate
Time Frame: through study completion, an average of 2 months
Beats per minute
through study completion, an average of 2 months
Pain
Time Frame: through study completion, an average of 2 months
NOL-index
through study completion, an average of 2 months
Pain
Time Frame: through study completion, an average of 2 months
ANI
through study completion, an average of 2 months
Sedation level
Time Frame: through study completion, an average of 2 months
Ramsay sedation scale. 1=Anxious and agitated or restless, or both. 2=Co-operative, oriented, and calm. 3=Responsive to commands only. 4=Exhibiting brisk response to light glabellar tap or loud auditory stimulus. 5=Exhibiting a sluggish response to light glabellar tap or loud auditory stimulus. 6=unresponsive. Values of 2-3 represent the better outcome.
through study completion, an average of 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Erasme University Hospital

Investigators

  • Principal Investigator: Peres-Bota Iulia, student, Erasme Hospital
  • Study Director: Barvais Luc, MDPhD, Erasme Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 12, 2018

Primary Completion (Anticipated)

March 31, 2018

Study Completion (Anticipated)

March 31, 2018

Study Registration Dates

First Submitted

February 14, 2018

First Submitted That Met QC Criteria

March 1, 2018

First Posted (Actual)

March 8, 2018

Study Record Updates

Last Update Posted (Actual)

March 13, 2018

Last Update Submitted That Met QC Criteria

March 9, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P2018/016

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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